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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE SAFELINK Holder with male luer lock, singlepacked, not made with natural rubber latex

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 Class 2 Device Recall VACUETTE SAFELINK Holder with male luer lock, singlepacked, not made with natural rubber latexsee related information
Date Initiated by FirmNovember 19, 2024
Date PostedJanuary 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0802-2025
Recall Event ID 95748
510(K)NumberK180545 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductVACUETTE SAFELINK, REF: 450210
Code Information UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
FEI Number 3000974732
Recalling Firm/
Manufacturer		 Greiner Bio-One GmbH
Bad Haller Strase 32
Kremsmunster Austria
For Additional Information Contact
75836791
Manufacturer Reason
for Recall		The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
FDA Determined
Cause 2		Process control
ActionOn 11/19/2024, customers and distributors were mailed and emailed recall notices asking them to do the following: 1) Stop using and isolate affected devices. 2) If the product has been further distributed or transferred to another location, notify those locations of the recall, and advise the name/location in the provided space on the attached Product Disposition Site Confirmation. 3) Complete and return the Product Disposition Site Confirmation form via email to recalls.us@gbo.com If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.
Quantity in Commerce188,800 pcs
DistributionUS Nationwide distribution in the states of IL, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMI
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